One of the amendments made to the regulations governing the conduct of clinical trials in India, which came into effect from January 2014, mandates audio visual (AV) recording of the informed consent process of all patients agreeing to participate in a clinical trial. Investigators have reported that the newly mandated AV consenting process (also known as consent on camera) has thrown up a range of practical and ethical issues and is being debated globally as well.
Express Pharma spoke to a number of doctors who are also investigators on clinical trials. The overall reaction was that the theory behind the mandate of AV consent was sound; putting it into practice was the tricky part. The reactions of patients may vary depending on the disease condition as well as many other variables. The regulator has mandated AV consents as superior to the written process in terms of generating more tamper-proof evidence and protecting the patient that consent was properly taken, but has this objective been fulfilled?
Consent over multiple sittings poses practical challenge
Dr Paramesh Diabetologist, Bangalore Diabetic Center |
For Dr Paramesh, a diabetologist at Bangalore Diabetic Center who has a decade of experience with clinical trials and has already done close to 50 AV consents, the loss of confidentiality of the patient is the main concern. As opposed to the previous practice of explaining the details of the trial verbally, documenting the queries made by the patient as well as the answers given, and then taking the person’s signature on the informed consent form, the new dispensation requires the entire process to be recorded.
Even though the patients are enrolling on a trial for their benefit as well as that of medical science, they draw the line at any loss of privacy. Dr Paramesh says that patients start having second thoughts when they realise that there may be a possibility that their details will be seen by people other than their doctors (i.e. members of ethics committees as they review the study etc) who may know them or their families.
Enrolling on a trial is still not considered the done thing and there is worry about how it may be perceived by peers and family friends. The unease is multiplied several fold with patients who have diseases like tuberculosis, HIV/AIDS or cancer where the social stigma is considerable. Dr Paramesh reasons that the drop out rate with such patients will be even higher due to the AV consenting decree.
Dr Paramesh points out that the informed consent process may not happen in one sitting, and could be spread over weeks or even months of multiple sittings. Compiling these recordings into a single AV recording could be cumbersome, as is the problem of storage of CDs: how to store, how long and where. In addition, he says that there may be technical glitches during the AV consent process. For instance, the camera may malfunction, etc which could create doubt that there was an abuse of the process. He recalled a case where the patient received a call during the consent process and the entire one sided conversation was recorded as part of the AV consent process! The doctor could not stop the camera as it would mean repeating the entire consent process again and the patient might have just backed out.
Even though it makes the process more tedious and fraught with practical difficulties, Dr Paramesh concedes that he does see the benefits of having an AV consent process, as it is proof that all the steps were followed in case there is a problem later. AV consenting could be restricted to selected cases, for example, when the patient is not mentally fit to give consent, or when children need to be consented.
He raises another point: consent for surgical procedures has been part of medical practice and has been not brought under the AV consent mandate. The main concern according to him, is the occurrence of deaths during trials, but deciding if it was due to the trial, merely during the trial or related to the investigational drug? He points out that even the polio vaccine still causes adverse reactions in some cases but this has not stopped our national polio vaccination programmes.
Thus he believes, “We have to look at the number of deaths versus those prevented. There are enough check and balances to stop the trial if there are too many deaths or adverse reactions.”
He also busts two myths. One, that India is a hub of clinical trials. He points out that as per clinicaltrials.gov, India has only two per cent of global trials. Secondly, contradictory to the popular image of only poor people signing up for trials, volunteers on his trials included a lawyer, a doctor and even an Assistant Commissioner of Police. People from all strata of society want to contribute to new drug development and have faith in the doctor.
Eroding the doctor-patient bond
Today, the doctor too is not above suspicion. The impact of adverse media coverage can be gauged by the fact that public ire, which was previously directed at organisations (sponsors and hospitals which are the sites for these studies) is now also viewing doctors with suspicion.
Dr Sarvajeet Pal Consultant Rheumatologist, Apollo Hospital, Hyderabad |
Take Dr Sarvajeet Pal, a consultant rheumatologist at Apollo Hospital, Hyderabad. 80 per cent of his patients are female, and the AV consent process makes them very uneasy; more so if their religion requires them to wear the burqa (Muslim) or the head veil/ghunghat. He reasons that he cannot ask these women to go against their religious/social norms and unveil for the AV consent process.
Dr Pal also opines that the DCGI’s move to cancel trials held in clinics was unwarranted. Most investigator-driven trials are in fact conducted by individual doctors in their clinics. Rather than cancelling all such trials, he suggests that the regulator should check clinics to see if they are suitable and then allow or stop a trial. His reasoning is that smaller trials which do not require hospitalisation should be allowed to be conducted in clinics as the quality of treatment is the same, whether conducted at clinics or hospitals. In fact in a larger hospital, the crowds and procedures may discourage patient enrolment.
The AV consent issue has strained the doctor-patient bond to such an extent that investigators themselves are re-considering their participation in clinical trials. Even though he has been associated with clinical trials for six to seven years, he says that today principal investigators in India are ‘frustrated.’
“The new guidelines have discouraged principal investigators from participating in trials,” he says. “Uneducated people are more suspicious, though educated people too object to the procedure. They do not understand about regulations; all they see is their doctor switching on a camera. The DCGI should probably send a person to do the recording then they may believe us when we say that it is part of new rules. Today it is the doctor who is being blamed. We are being forced to follow protocol. The higher authorities should try something else which is satisfying to all: the regulator, the doctor as well as the patient.”
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‘Clinical trials has taken a beating in India but we are going to rise again’ As Chairman of the six-member Expert Committee for Reforms in Drug Regulation and Clinical Trials set up by the MoHFW, Govt of India last year Prof Roy Chaudhury has included recommendations to this effect and in fact the industry has been protesting the regularisation of all these practices, saying that some of them are not planned out well. Prof Roy Chaudhury’s message to patients is equally important: that they must be alert, should not hesitate to ask questions and find all all they can about the place where the trial is being conducted. They must feel empowered enough to find out at least if the centres where they are planning to be clinical trial subjects have accreditation and if the ethics committee at the centre is functioning properly and has a good track record. If this is the case, if they are reasonably assured that the centre, the investigator and the ethics committee is good, then is there is nothing wrong in the conduct of the trial. If they do not understand anything on the informed consent form or on the patient information sheet, like technical terms, they should ask the ethics committee members for clarification. – Prof Ranjit Roy Chaudhury, Chairman, Task Force for Research, Apollo Hospitals Group |
When faced with no choice
It is becoming more obvious that the reaction to the AV consenting process varies according to the disease condition and the seriousness of the condition. Cancer patients who have exhausted all available treatment and for whom clinical trials could be the last hope to prolong their life span, may have no choice but to allow a video recording.
But oncologists report that even when faced with no alternative, quite a few patients who would have previously signed on might be put off. Cancer patients have to cope with the trauma of changed appearance (hair loss, etc due to chemotherapy) and this leads to an aversion to being photographed, much less being videographed. To top it, the doctor is unable to share the AV recording, in the way that he could allow the patient to take home the informed consent forms so that the patient could discuss them with family members.
Dr Srinivasan Clinical Oncologist Dr Kamakshi Memorial Hospital, Chennai |
“AV recording is seen as the doctor not being as transparent as before,” says Dr Srinivasan, a clinical oncologist, at Dr Kamakshi Memorial Hospital, Chennai. He thus feels that by being bound to follow the AV consent process, the doctor may be indirectly denying them the freedom to participate in a trial and in turn denying them life. He does concede that there may have been some cases where the informed consent process was not being done properly but reasons that the whole fraternity cannot be penalise for the wrongdoings of a few. He suggests that cancer trials should be exempt from the AV consent process for this reason.
Dr Srinivasan points out that AV consent is not mandatory in western countries like the US and in fact, there is a lot of encouragement for conducting clinical trials. It is only in India that clinical trials have not been projected in the right perspective, he points out.
Dr Chirag D Bhatt Vitreo Retinal Consultant, Susrut Eye Foundation and Research Center, Kolkata |
Dr Chirag D Bhatt, a vitreo retinal consultant at Susrut Eye Foundation and Research Center, Kolkata does not face as much back lash to the AV consenting process from his patients, probably because eye diseases are not associated with any social sigma nor are accompanied by major disfigurement. “AV consent will increase transparency and may be good in the long term but it will strain the doctor -patient rapport,” is his assessment.
He explains that not all patients may be educated enough to understand so doctors have to then spend more time on the consent process. Patients may become camera conscious, and may appear stiff, give short abrupt replies which may appear unnatural to a reviewer. He expresses hope that this will change in time.
When companies sign on doctors for trials, they prefer those with a heavy patient load but these doctors may not have the time, especially if AV consent adds to the patient recruitment time. Clinical trials require a different mindset, and skills like record maintenance etc but Dr Bhatt reckons that doctors like him need to be part of clinical trials as its their contribution to science.
Going by the experience of these doctors, the AV consent process seems to be in direct contradiction of the tenets of the Hippocratic oath, where all doctors are duty bound to do no harm, keep their patients’ well being paramount and above all, maintain strict confidentiality.
Suneela Thatte President, Indian Society for Clinical Research (ISCR) |
Commenting on the overall scenario, Suneela Thatte, President, Indian Society for Clinical Research (ISCR) points out, “Patients help patients. Today all of us have access to better and newer treatments because of patients who have participated in clinical trials. Thus, we all are beneficiaries of clinical research. Yet it is unfortunate that the progress of clinical research in India has been stalled by several extraneous factors denying patients the opportunity to participate in and benefit from ongoing clinical research. The impact of this on patients is huge. A slowdown in clinical research in the country means little or no access to newer and better medicines for our patients and a rising disease burden.”
This is the reason why ISCR has chosen ‘Patients First’ as the theme for this year’s International Clinical Trials Day which falls on May 20th. This day commemorates the world’s first controlled clinical trial on a group of sailors suffering from scurvy, conducted in 1747, by Dr James Lind, a Scottish physician. Through their participation in the study, the sailors contributed to the discovery that Vitamin C was an effective treatment for scurvy. Thatte also appealed to the media, saying that it had the potential to play an transformational role in highlighting the value of clinical research and creating confidence about participating in clinical research amongst the public at large.
A research paper authored by Niranjan G Kulkarni, Jeroze J Dalal, and Tejashree N Kulkarni, titled ‘Audio-video recording of informed consent process: Boon or bane’ provides both sides of the debate. Published in Perspectives of Clinical Research, Jan-March 2014, the authors make the point that while AV recording of the consent process will definitely help to record the actual consent process, ascertaining that the participant has voluntarily consented still remains debatable. They also point out that until expectations of regulators from the AV recording are crystal clear, the records may work as double-edged sword for the investigators and sponsors, because AV recordings once made becomes an irreversible process and mistakes made by the investigator would be difficult to be corrected and can be misused. Even with these challenges, the authors conclude saying that is their highest priority to reassure the government and community at large about standards adopted by the industry and AV recording would be a very positive step ahead to build trust and confidence in the clinical research.
Thus the industry is willing to implement amendments aimed at patient safety, but the regulator will need to decide if the purpose is truly being served?